MAUDE Adverse Event Report: MEDTECH SA ROSA SURGICAL DEVICE; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA SURGICAL DEVICE

Device Problem Computer Software Problem (1112)

Patient Problem No Code Available (3191)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.(b)(4).

Event Description

It was reported that multiple 3d reconstruction problems occurred during the preparation of the surgery.

Manufacturer Narrative

A test was performed to recreate the event on another rosa device with (b)(4) software version with the ct as reference.A crash occured at the same time than described in the complaint.The error is an insufficient memory to allow computing of 3d reconstruction of the ct.Nevertheless 3d reconstruction button was still available and allow to display the interface for computing 3d reconstruction.It indicates that software will compute 3d reconstruction based on the ¿brown-colored¿ part of the image displayed on axial, sagittal and coronal views.It is a lot of information and may be the cause of the insufficient memory.Plus, on the image the ct-scan head clamp is clearly visible.It is an extra information which will be used for 3d reconstruction and may contribute to fill the memory during computation.This information is not necessary for rosa usage.According to the results of the technical investigation, the event was caused by a user error.Too many informations were present on the loaded images and did not allow (b)(4)to create 3d reconstruction because of an insufficient memory.

• Brand Name: ROSA SURGICAL DEVICE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; languedoc-roussillon 34000 ; FR 34000
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7112069
• MDR Text Key: 94636792
• Report Number: 3009185973-2017-00821
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA SURGICAL DEVICE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1